Coamatic Plasminogen
by Instrumentation Laboratory CO
510(k) K974711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974711 | Date1 May 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GGP
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7290
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Coamatic Plasminogen is an in vitro diagnostic test classified as a Test, Qualitative and Quantitative Factor Deficiency, designed for the quantitative determination of plasminogen activity in human citrated plasma. It operates on automated laboratory equipment, microplate, and manual methods to measure plasminogen levels, aiding in the assessment of fibrinolytic disorders. The device adheres to FDA-substantiated equivalence standards under the 510(k) clearance process (K974711).
This test is supplied as a reagent kit for use in clinical hematology laboratories, where citrated plasma samples are processed to quantify plasminogen activity. It is intended for single-use per manufacturer specifications and requires automated or manual laboratory instrumentation for analysis. The device is regulated under FDA classification II (device class=2) and complies with regulation number 864.7290 for in vitro diagnostic tests. No sterility or MRI safety information is provided in the available data.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 1 Oct 2026
What is the Coamatic Plasminogen test used for?
The Coamatic Plasminogen test is designed for the quantitative determination of plasminogen activity in human citrated plasma. It helps clinicians assess fibrinolytic disorders by measuring plasminogen levels, which are critical for evaluating conditions related to blood clotting and fibrinolysis. The test supports diagnostic decision-making in hematology laboratories.
How is the Coamatic Plasminogen test supplied, and what equipment is required?
The Coamatic Plasminogen test is supplied as a reagent kit. It is intended for single-use per manufacturer specifications and requires either automated laboratory equipment or manual laboratory instrumentation for analysis. The kit includes components necessary for processing citrated plasma samples on microplates, ensuring compatibility with standard hematology workflows.
Is sterility or MRI safety information provided for the Coamatic Plasminogen test?
The available data does not include any information regarding sterility or MRI safety for the Coamatic Plasminogen test. Clinicians should follow standard laboratory practices for handling and storage, and ensure compatibility with their specific equipment and environment.
What regulatory pathway does the Coamatic Plasminogen test follow?
The Coamatic Plasminogen test is regulated under the FDA’s 510(k) clearance process, classified as a Class II device (device class=2) under regulation number 864.7290. It was granted substantial equivalence by the FDA through a traditional review pathway, with the clearance number K974711. This classification applies to in vitro diagnostic tests for qualitative and quantitative factor deficiencies.
Are there different models or sizes available for the Coamatic Plasminogen test?
The Coamatic Plasminogen test is supplied as a single reagent kit designed for quantitative plasminogen measurement. While the data does not specify multiple models or sizes, the kit is intended for use with automated or manual laboratory systems, ensuring flexibility in clinical settings. Always verify compatibility with your specific instrumentation before use.